Delivery device for a stented prosthetic heart valve

ABSTRACT

A delivery device for percutaneously delivering a stented prosthetic heart valve includes a capsule assembly, a handle, and an outer stability shaft. The capsule assembly includes a capsule and a proximal shaft coupled to the capsule. The capsule includes an expanded configuration wherein the capsule has a first outer diameter, and a collapsed configuration wherein the capsule has a second outer diameter smaller than the first outer diameter. The outer stability shaft defines a lumen and is coupled to the handle and configured to receive the proximal shaft within the lumen of the outer stability shaft. The outer stability shaft has an inner diameter, wherein the first outer diameter of the capsule is greater than the inner diameter of the outer stability shaft and the second outer diameter of the capsule is smaller than the inner diameter of the outer stability shaft.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. § 119(e) of thefiling date of U.S. Provisional Application No. 62/278,324 filed Jan.13, 2016, the contents of which are incorporated by reference herein intheir entirety.

FIELD OF INVENTION

The present invention relates to systems and methods for percutaneoustranscatheter delivery and implantation of a stented prosthetic heartvalve. More particularly, it relates to the delivery device and methodsfor the centering of a stented prosthetic heart valve within an annulusof a native heart valve.

BACKGROUND

Heart valves are sometimes damaged by disease or by aging, resulting inproblems with the proper functioning of the valve. Heart valvereplacement has become a routine surgical procedure for patientssuffering from valve dysfunctions. Traditional open surgery inflictssignificant patient trauma and discomfort, requires extensiverecuperation times, and may result in life-threatening complications.

To address these concerns, efforts have been made to perform cardiacvalve replacements using minimally-invasive techniques. In thesemethods, laparoscopic instruments are employed to make small openingsthrough the patient's ribs to provide access to the heart. Whileconsiderable effort has been devoted to such techniques, widespreadacceptance has been limited by the clinician's ability to access onlycertain regions of the heart using laparoscopic instruments.

Still other efforts have been focused upon percutaneous transcatheter(or transluminal) delivery and implantation of replacement cardiacvalves to solve the problems presented by traditional open surgery andminimally-invasive surgical methods. In such methods, a stentedprosthetic heart valve is compacted for delivery in a catheter and thenadvanced, for example through an opening in the femoral artery, andthrough the descending aorta to the heart, where the stented prostheticheart valve is then deployed in the valve annulus (e.g., the aorticvalve annulus).

Various types and configurations of stented prosthetic heart valves areavailable for percutaneous valve replacement procedures. In general,stented prosthetic heart valve designs attempt to replicate the functionof the valve being replaced and thus will include valve leaflet-likestructures. Valve prostheses are generally formed by attaching abioprosthetic valve to a frame made of a wire or a network of wires.Such a stented prosthetic heart valve can be compressed radially tointroduce the stented prosthetic heart valve into the body of thepatient percutaneously through a catheter. The stented prosthetic heartvalve may be deployed by radially expanding it once positioned at thedesired treatment site. If the deployed prosthesis is incorrectlypositioned relative to the valve annulus, serious complications mayarise, including paravalvular leakage (PVL) or the requirement forplacement of a permanent pacemaker.

A standard delivery device for percutaneous transcatheter delivery of astented prosthetic heart valve is shown in FIGS. 1A-1C. FIG. 1A shows adelivery device 1100 in a delivery configuration. FIG. 1B shows deliverydevice 1100 with a capsule 1108 retracted. FIG. 1C shows planer orlongitudinal movement of capsule 1108 of delivery device 1100. Deliverydevice 1100 includes a handle 1140, an outer stability shaft 1110, aproximal shaft 1118 coupled to capsule 1108, and an inner shaft 1114. Astented prosthetic heart valve (not shown) in a radially compresseddelivery configuration is compressively retained within capsule 1108 fordelivery to the treatment site. A gap distance G1 is the distancebetween a distal end 1126 of outer stability shaft 1110 and a proximalend 1109 of capsule 1108. Gap distance G1 is required to permitretraction of capsule 1108, along a longitudinal axis LA_(d), to fullyrelease the stented prosthetic heart valve (not shown) as shown in FIG.1B. Gap distance G1 plus the length of capsule 1108 combine to form alever arm L1, as shown in FIG. 1A. Stated another way, lever arm L1includes gap distance G1 and the length of capsule 1108 and extends fromdistal end 1126 of outer stability shaft 1110 to the distal tip ofdelivery device 1100.

Prior to release of the stented prosthetic heart valve (not shown) atthe treatment site, it may be desired to adjust the centered position ofcapsule 1108 in relation to a valve annulus utilizing a steeringmechanism 1152 of delivery device 1100. Steering mechanism 1152 isactuated with a steering actuator 1148 of handle 1140, as shown in FIG.1C. However, lever arm L1 may result in an inaccurate or unpredictablesteering of capsule 1108 and stented prosthetic heart valve retainedtherein. More particularly, small movements of steering actuator 1148,combined with the relatively long length of lever arm L1, translate to arelatively large planar movement PM_(I1) or PM_(r1) and a largedeflection distance D_(d1) from longitudinal axis LA_(d), of capsule1108 and stented prosthetic heart valve retained therein.

Accordingly, there is a need for an improved delivery device design andmethods to provide smaller centering adjustment movement of capsule 1108for more accurate positioning of a stented prosthetic heart valve toreduce the instances of post procedure complications.

SUMMARY OF THE INVENTION

Embodiments hereof relate to a delivery device for percutaneouslydelivering a stented prosthetic heart valve to the site of a damaged ordiseased native valve. The stented prosthetic heart valve is radiallyexpandable from a radially compressed delivery configuration to aradially expanded deployed configuration. The delivery device includes acapsule assembly, a handle, and an outer stability shaft. The capsuleassembly includes a capsule and a proximal shaft coupled to a proximalend of the capsule. The capsule includes an expanded configurationwherein the capsule has a first outer diameter and is configured tocompressively constrain the stented prosthetic heart valve, and acollapsed configuration wherein the capsule has a second outer diametersmaller than the first outer diameter. The handle includes a housing andan actuator mechanism, wherein the actuator mechanism is coupled to aproximal portion of the proximal shaft and is configured to selectivelymove the proximal shaft and the capsule relative to the housing torelease the stented prosthetic heart valve. The outer stability shaftdefines a lumen and is coupled to the handle and configured to receivethe proximal shaft within the lumen of the outer stability shaft, theouter stability shaft having an inner diameter, wherein the first outerdiameter of the capsule is greater than the inner diameter of the outerstability shaft and the second outer diameter of the capsule is smallerthan the inner diameter of the outer stability shaft.

Embodiments hereof also relate to a delivery device for percutaneouslydelivering a stented prosthetic heart valve to the site of a damaged ordiseased native valve. The stented prosthetic heart valve is radiallyexpandable from a radially compressed delivery configuration to aradially expanded deployed configuration. The delivery device includes acapsule assembly, a handle, and an outer stability shaft. The capsuleassembly includes a capsule and a proximal shaft coupled to a proximalend of the capsule. The capsule includes an expanded configurationwherein the capsule is configured to compressively constrain the stentedprosthetic heart valve in the radially compressed deliveryconfiguration, and a collapsed configuration wherein the capsule doesnot surround the stented prosthetic heart valve. The handle includes ahousing and an actuator mechanism, wherein the actuator mechanism iscoupled to a proximal portion of the proximal shaft and is configured toselectively move the proximal shaft and the capsule relative to thehousing to release the stented prosthetic heart valve. The outerstability shaft defines a lumen and is coupled to the handle andconfigured to receive the proximal shaft within the lumen of the outerstability shaft. The proximal end of the capsule is disposed distal to adistal end of the outer stability shaft when the capsule is in theexpanded configuration and the capsule is disposed within the lumen ofthe outer stability shaft when the capsule is in the collapsedconfiguration.

Embodiments hereof also relate to a method for manipulating a deliverydevice loaded with a radially expandable stented prosthetic heart valvein a radially compressed delivery configuration, through a patient'svasculature, to a treatment site. The stented prosthetic heart valveincludes a stent frame to which a valve structure is attached. Thedelivery device, in the delivery configuration, includes a capsuleconstraining the stented prosthetic heart valve and having a first outerdiameter, and a proximal shaft extending proximally from a proximal endof the capsule. The delivery device further includes an outer stabilityshaft surrounding the proximal shaft in the delivery configuration, witha distal end of the outer stability shaft terminating proximal of thecapsule. The capsule is retracted proximally to release the stentedprosthetic heart valve from the capsule. The capsule slides relative tothe outer stability shaft to a collapsed configuration with a secondouter diameter smaller than the first outer diameter. The capsule isretracted within the outer stability shaft.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1A is a simplified illustration of a prior art transcatheterdelivery device in a delivery configuration.

FIG. 1B is a simplified illustration of a prior art transcatheterdelivery device with a retracted capsule assembly.

FIG. 1C is a simplified illustration of a prior art transcatheterdelivery device showing planer movement of the capsule.

FIG. 2A is a side illustration of an embodiment of a delivery deviceaccording to an embodiment hereof, wherein a capsule of the deliverydevice is in an expanded configuration and disposed distal to a distalend of an outer stability shaft of the delivery device.

FIG. 2B is a side illustration of the delivery device of FIG. 2A,wherein the capsule is in a collapsed configuration and disposed withinthe outer stability shaft of the delivery device.

FIG. 3 is an exploded perspective illustration of the delivery device ofFIG. 2A.

FIG. 4A is a cutaway illustration of the delivery device of FIG. 2A withthe capsule in the expanded configuration and disposed distal to thedistal end of the outer stability shaft of the delivery device.

FIG. 4B is a cutaway illustration of the delivery device of FIG. 2B withthe capsule in the collapsed configuration and disposed within the outerstability shaft of the delivery device.

FIG. 4C is an end view of the delivery device of FIG. 2A comparing thecapsule's expanded configuration and collapsed configuration.

FIG. 5 is an end view of the capsule of the delivery device of FIG. 2A,wherein the capsule is shown in the collapsed configuration.

FIG. 6A is a front view of a wire structure of the capsule of FIG. 5,wherein the wire structure is laid out flat for illustrative purposesonly.

FIG. 6B is a front view of a wire structure of a capsule according toanother embodiment hereof, wherein the wire structure is laid out flatfor illustrative purposes only.

FIG. 6C is a front view of a wire structure of a capsule according toanother embodiment hereof, wherein the wire structure is laid out flatfor illustrative purposes only.

FIG. 6D is a front view of a wire structure of a capsule according toanother embodiment hereof, wherein the wire structure is laid out flatfor illustrative purposes only.

FIG. 6E is a front view of a wire structure of a capsule according toanother embodiment hereof, wherein the wire structure is laid out flatfor illustrative purposes only.

FIG. 6F is a perspective view of the wire structure of FIG. 6E

FIG. 7A is a perspective view of the wire structure of FIG. 6A.

FIG. 7B is a top view of the wire structure of FIG. 6A.

FIG. 8A is an end view of the capsule of FIG. 5, wherein the capsule isshown in the collapsed configuration.

FIG. 8B is an end view of the capsule of FIG. 5, wherein the capsule isshown in the expanded configuration.

FIG. 9A is an end view of a capsule according to another embodimenthereof, wherein the capsule is shown in an expanded configuration.

FIG. 9B is an end view of the capsule of FIG. 9A, wherein the capsule isshown in a relaxed or intermediate configuration.

FIG. 9C is an end view of the capsule of FIG. 9A, wherein the capsule isshown in a collapsed or folded configuration.

FIG. 10A is perspective and cutaway view of the capsule of FIG. 9A,wherein the capsule is shown in the expanded configuration.

FIG. 10B is a perspective and cutaway view of the capsule of FIG. 9C,wherein the capsule is in the collapsed or folded configuration.

FIG. 10C is an end view of a capsule according to another embodimenthereof, wherein the capsule is shown in an expanded configuration.

FIG. 10D is an end view of the capsule of FIG. 10C, wherein the capsuleis shown in a collapsed or folded configuration.

FIG. 11A is a side illustration of another embodiment of a deliverydevice of the present disclosure, with a steering mechanism, and acapsule in an expanded configuration.

FIG. 11B is a side illustration of the delivery device of FIG. 11A withthe capsule in a collapsed configuration.

FIG. 11C is a side illustration of the delivery device of FIG. 11A withthe capsule in the expanded configuration, showing the delivery devicebending in one plane and a deflection distance of the capsule.

FIG. 12 is a cross-sectional view of a steering mechanism of FIG. 11Ataken along line 12-12 of FIG. 11A.

FIGS. 13A is a simplified illustration of the delivery device of FIG.2A, wherein the delivery device is in a delivery configuration andpositioned within an aorta.

FIG. 13B is a simplified illustration of the delivery device of FIG. 2Aand an expanding stented prosthetic heart valve.

FIG. 13C is a simplified illustration of the delivery device of FIG. 2Aand the stented prosthetic heart valve in a radially expanded deployedconfiguration.

FIG. 14A is a simplified illustration of the delivery device of FIG. 2A,wherein the delivery device is in a delivery configuration and is notcentered on a longitudinal axis of a valve annulus.

FIG. 14B is a simplified illustration of the delivery device of FIG. 2A,wherein the delivery device is adjusted to align with the longitudinalaxis of the valve annulus.

FIG. 14C is a simplified illustration of the delivery device of FIG. 2A,wherein the delivery device is centered on the longitudinal axis of thevalve annulus.

FIG. 14D is a simplified illustration of the delivery device of FIG. 2Aand an expanding stented prosthetic heart valve.

FIG. 14E is a simplified illustration of the delivery device of FIG. 2Aand the stented prosthetic heart valve in a radially expanded deployedconfiguration.

FIG. 15 is an exploded perspective illustration of a delivery deviceaccording to another embodiment hereof, wherein the delivery deviceincludes the capsule of FIG. 2A as well as a second or delivery capsule.

FIG. 16 is a cutaway illustration of the delivery device of FIG. 15,wherein both the capsule of FIG. 2A and the second or delivery capsuleare in expanded configurations and disposed distal to the distal end ofthe outer stability shaft of the delivery device.

DETAILED DESCRIPTION

Specific embodiments of the present invention are now described withreference to the figures, wherein like reference numbers indicateidentical or functionally similar elements. The terms “distal” and“proximal”, when used in the following description to refer to acatheter or delivery device, are with respect to a position or directionrelative to the treating clinician. Thus, “distal” and “distally” referto positions distant from, or in a direction away from, the clinicianand “proximal” and “proximally” refer to positions near, or in adirection toward, the clinician.

The following detailed description is merely exemplary in nature and isnot intended to limit the invention or the application and uses of theinvention. Furthermore, there is no intention to be bound by anyexpressed or implied theory presented in the preceding technical field,background, brief summary, or the following detailed description.

As referred to herein, the stented prosthetic heart valves used inaccordance with and/or as part of the various systems, devices, andmethods of the present disclosure may include a wide variety ofdifferent configurations, such as a bioprosthetic heart valve havingtissue leaflets or a synthetic heart valve having polymeric, metallic,or tissue-engineered leaflets, and can be specifically configured forreplacing any heart valve.

In general terms, the stented prosthetic heart valve of the presentdisclosure includes a stent supporting a valve structure which may beconstructed from tissue and/or synthetic materials, with the stentedprosthetic heart valve having a radially expanded deployed configurationthat is collapsible to a radially compressed delivery configuration forloading within a delivery device. The stented prosthetic heart valve isusually constructed from a self-expanding material that is configured toself-deploy or expand when released from the delivery device. Forexample, the stented prosthetic heart valve useful with the presentdisclosure can be a stented prosthetic heart valve sold under the tradename CoreValve® available from Medtronic CoreValve, LLC. Othernon-limiting examples of the stented prosthetic heart valves useful withthe systems, devices, and methods of the present disclosure aredescribed in U.S. Pat. No. 7,662,186 to Bragga and U.S. Pat. No.7,740,655 to Birdsall, each of which are incorporated in their entiretyby reference herein. The stents or stent frames are support structuresthat comprise a number of struts or wire portions arranged relative toeach other to provide a desired compressibility and strength to theprosthetic heart valve. In general terms, the stents or stent frames ofthe present disclosure are generally tubular support structures havingan internal area in which valve structure leaflets will be secured.

With the above understanding of the stented prosthetic heart valve inmind, a delivery device 100 is shown in FIGS. 2A and 2B. Delivery device100 includes an outer stability shaft 110 and a capsule 108 forpercutaneously delivering and implanting a stented prosthetic heartvalve (not shown) according to an embodiment of the present invention.FIG. 2A illustrates delivery device 100 prior to retraction of capsule108, with capsule 108 being in an expanded configuration, and FIG. 2Billustrates delivery device 100 after retraction of capsule 108 (notshown in FIG. 2B) with capsule 108 being in a collapsed configurationwithin outer stability shaft 110, as will be described in more detailherein. Capsule 108 is thus configured to transition between theexpanded configuration in which capsule 108 is disposed distal to outerstability shaft 110 such that the capsule surrounds and compressivelyretains a stented prosthetic heart valve, and the collapsedconfiguration in which the capsule is proximally retracted into outerstability shaft 110. Since capsule 108 is configured to be collapsed onretraction thereof into outer stability shaft 110, capsule 108 may bedisposed directly adjacent to the distal end of stability shaft 110 aswill be described in more detail herein.

Delivery device 100 includes a handle 140, outer stability shaft 110, acapsule assembly 107, and an inner shaft assembly 104. Components inaccordance with the embodiment of delivery device 100 of FIGS. 2A and 2Bare presented in greater detail in FIGS. 3-4C. Various features of thecomponents of delivery device 100 reflected in FIGS. 3-4C and describedbelow can be modified or replaced with differing structures and/ormechanisms. Delivery device 100, described in greater detail below, ismerely an exemplary embodiment of a transcatheter delivery deviceaccording to an embodiment hereof and modifications can be made to theembodiments described herein, without departing from the spirit andscope of the present invention. The present disclosure is in no waylimited to capsule assembly 107, inner shaft assembly 104, outerstability shaft 110, and handle 140, shown and described below.Components of delivery device 100 may assume different forms andconstruction based upon application needs as described in greater detailin U.S. Pat. No. 7,662,186 to Bragga and U.S. Pat. No. 7,740,655 toBirdsall, each of which were previously incorporated by reference.Therefore, the following detailed description is not meant to belimiting. Further, the systems and functions described below can beimplemented in many different embodiments of hardware. Any actualhardware described is not meant to be limiting. The operation andbehavior of the systems and methods presented are described with theunderstanding that modifications and variations of the embodiments arepossible given the level of detail presented.

Handle 140 includes a housing 142 and an actuator mechanism 144 retainedtherein. More particularly, handle 140 is configured to maintainportions of actuator mechanism 144 within a cavity (not shown), definedby housing 142, as shown in FIGS. 2A and 2B. In the embodiment shown inFIGS. 3-4B, housing 140 further forms a longitudinal slot 146 throughwhich actuator mechanism 144 extends for interfacing by a user. Handle140 provides a surface for convenient handling and grasping by a user,and can have a generally cylindrical shape as shown. While handle 140 ofFIGS. 3-4B is shown with a cylindrical shape, it is not meant to limitthe design, and other shapes and sizes are contemplated based on theapplication requirements. Handle 140 can assume a variety ofconfigurations described in greater detail in U.S. Pat. No. 8,579,963 toTabor, which is incorporated in its entirety by reference herein.Actuator mechanism 144 is generally constructed to provide selectiveretraction/advancement of capsule assembly 107 and can have a variety ofconstructions and/or devices capable of providing the desired userinterface. Actuator mechanism 144 is further described in U.S. Pat. No.8,579,963 to Tabor, previously incorporated by reference.

Capsule assembly 107 is coaxially and slidably disposed between innershaft assembly 104 and outer stability shaft 110. Stated another way,capsule assembly 107 may be longitudinally moved relative to inner shaftassembly 104 and outer stability shaft 110 as described in more detailherein. With reference to FIGS. 3-4C, capsule assembly 107 includescapsule 108 and a proximal shaft 118, and defines a lumen 112 extendingfrom a proximal end 130 of proximal shaft 118 to a distal end 132 ofcapsule 108. Although capsule assembly 107 is described herein asincluding capsule 108 and proximal shaft 118, capsule 108 may simply bean extension of proximal shaft 118. The length and thickness of capsule108 are determined by the requirements of the specific application.Proximal shaft 118 is configured for fixed connection to capsule 108 ata connection point 116 at a proximal end 109 of capsule 108 for example,and not by way of limitation, by fusing, welding, adhesive, sutures, orother means suitable for the purposes described herein, and extendsproximally from capsule 108, with proximal shaft 118 configured forfixed connection to handle 140. More particularly, proximal shaft 118 ofcapsule assembly 107 extends proximally into housing 142 of handle 140and a proximal portion 131 of proximal shaft 118 is rigidly connected toactuator mechanism 144 of handle 140. Proximal portion 131 is coupled toactuator mechanism 144 such that movement of actuator mechanism 144causes capsule assembly 107 to move relative to outer stability shaft110 and inner shaft assembly 104. Proximal shaft 118 may be coupled toactuator mechanism 144, for example, and not by way of limitation byadhesives, welding, clamping, and other coupling devices as appropriate.Capsule assembly 107 is thus movable relative to handle 140, outerstability shaft 110, and inner shaft assembly 104 by actuator mechanism144.

However, if actuator mechanism 144 is not moved and handle 140 is moved,capsule assembly 107 moves with handle 140, not relative to handle 140.

Inner shaft assembly 104 extends within lumen 112 of capsule assembly107. Inner shaft assembly 104 includes an inner shaft 114, a retentionmember 120, and a tip 122. Inner shaft 114 extends from a proximal end134 of inner shaft 114 to a distal end 136 of inner shaft 114. Distalend 136 of inner shaft 114 connects or is attached to retention member120, and retention member 120 connects or is attached to tip 122. Thecomponents of inner shaft assembly 104 combine to define a continuouslumen 123, which is sized to receive an auxiliary component such as aguidewire (not shown). Although inner shaft assembly 104 is describedherein as including inner shaft 114, retention member 120, and tip 122,retention member 120 and tip 122 may simply be an extension of innershaft 114. Inner shaft 114 of inner shaft assembly 104 extendsproximally through housing 142 of handle 140, and is rigidly connectedto handle 140 such that lumen 123 provides access for auxiliarycomponents (e.g., a guidewire) therein. Inner shaft 114 may be coupledto handle 140, for example, and not by way of limitation, by adhesives,welding, clamping, and other coupling devices as appropriate. Duringsliding or longitudinal movement of capsule assembly 107 relativethereto, inner shaft assembly 104 is fixed relative to handle 140. Innershaft assembly 104 can assume a variety of configurations described ingreater detail in U.S. Pat. No. 8,579,963 to Tabor, previouslyincorporated by reference.

Outer stability shaft 110 is disposed over a portion of capsule assembly107. Outer stability shaft 110 extends distally from handle 140, andencompasses and surrounds a portion of the length of proximal shaft 118,thus stabilizing at least a portion of proximal shaft 118 as shown inFIG. 4A such that outer stability shaft 110 provides stability todelivery device 100. Outer stability shaft 110 has a proximal end 124and a distal end 126 that defines a lumen 128 therein. Lumen 128 ofouter stability shaft 110 is sized to coaxially receive capsule assembly107, and in particular proximal shaft 118, in a manner permitting thesliding of proximal shaft 118 relative to outer stability shaft 110.Outer stability shaft 110 is configured for fixed connection to handle140. More particularly, handle 140 has a distal end 149 configured toaccept proximal end 124 of outer stability shaft 110. Outer stabilityshaft 110 may be coupled to handle 140, for example, and not by way oflimitations, by adhesives, welding, clamping, and other couplingdevices, as appropriate. Outer stability shaft 110 can assume a varietyof configurations described in greater detail in U.S. Pat. No. 8,579,963to Tabor, previously incorporated by reference.

According to embodiments hereof, capsule 108 is configured to becollapsible upon retraction thereof into outer stability shaft 110. FIG.4A shows delivery device 100 with capsule 108 in the expandedconfiguration, in which a stented prosthetic heart valve (not shown) ina radially compressed delivery configuration is loaded therein. As shownin FIGS. 4A and 4C, when in the expanded configuration, capsule 108 hasan outer diameter OD_(e) and is coaxially disposed over retention member120 of inner shaft assembly 104. Outer diameter OD_(e) is greater thanan inner diameter ID_(a) of outer stability shaft 110. However, whencapsule 108 is in the collapsed configuration, as shown in FIGS. 4B and4C, capsule 108 has an outer diameter OD_(c), which is smaller thaninner diameter ID_(a) of outer stability shaft 110. More particularly,as previously described, capsule assembly 107, including capsule 108 andproximal shaft 118, can be retracted in a proximal direction relative toinner shaft assembly 104, outer stability shaft 110, and housing 142 ofhandle 140 such that capsule 108 is proximally retracted into outerstability shaft 110 as shown in FIG. 4B. When retracted, capsule 108collapses to outer diameter OD_(c), which is smaller than inner diameterID_(a) of outer stability shaft 110. Thus, capsule 108 transitions fromthe expanded configuration of FIG. 4A to the collapsed configuration ofFIG. 4B when retracted into lumen 128 of outer stability shaft 110.Capsule 108 retracts into lumen 128 of outer stability shaft 110 suchthat capsule 108 does not surround the stented prosthetic heart valve(not shown), and the stented prosthetic heart valve (not shown) radiallyexpands to its radially expanded deployed configuration. Thus, capsule108 is in its expanded configuration prior to retraction of capsuleassembly 107 and release of the stented prosthetic heart valve, andcapsule 108 is in its collapsed configuration after retraction ofcapsule assembly 107 and release of the stented prosthetic heart valve.FIG. 4C shows an end view comparison of capsule 108 in the expanded andcollapsed configurations. In the expanded configuration, capsule 108with outer diameter OD_(e) is shown in relation to lumen 123 of innershaft 114, lumen 112 of proximal shaft 118, and lumen 128 of outerstability shaft 110 (obscured in FIG. 4C by capsule 108 in the expandedconfiguration). In the collapsed configuration, capsule 108 with outerdiameter OD_(c) is shown in relation to lumen 123 of inner shaft 114,lumen 112 of proximal shaft 118 (obscured by capsule 108 in thecollapsed configuration), and outer stability shaft 110.

Since capsule 108 is configured to be collapsible upon retractionthereof into outer stability shaft 110, distal end 126 of outerstability shaft 110 may be disposed directly adjacent to proximal end109 of capsule 108. Stated another way, since capsule 108 is configuredto be collapsible upon retraction thereof into outer stability shaft110, it is not required to leave a gap between distal end 126 of outerstability shaft 110 and proximal end 109 of capsule 108 sufficient topermit retraction of capsule 108. Rather, outer stability shaft 110extends such that gap distance G2, as shown in FIG. 4A, between proximalend 109 of capsule 108 and distal end 126 of outer stability shaft 110,is minimized and in the range of 0 mm to 10 mm. Gap distance G2accommodates a smooth but relatively short taper between capsule 108 andproximal shaft 118 as shown in FIG. 4A. As such, as used herein,“directly adjacent” includes when distal end 126 of outer stabilityshaft 110 is disposed between 0 mm and 10 mm relative to proximal end109 of capsule 108. In an embodiment, distal end 126 of outer stabilityshaft 110 may abut against or contact proximal end 109 of capsule 108.

FIGS. 5-8B illustrate how capsule 108 is configured to be collapsibleupon retraction thereof into outer stability shaft 110 (not shown inFIGS. 5-8B) according to an embodiment hereof. More particularly,capsule 108 includes a wire structure 200, a liner 300, and a jacket400. Wire structure 200 is coupled between liner 300 and jacket 400, forexample, and not by way of limitation, by lamination, embedding, orother methods suitable for the purposes described herein. Liner 300 maybe constructed, for example, and not by way of limitation, of Teflon®,polytetrafluoroethylene (PTFE), polyethylene, polyethylene terephthalate(PET), polyester, or other materials suitable for the purposes of thepresent disclosure. Jacket 400 may be constructed, for example, and notby way of limitation, of polyurethane (e.g. Peliethane©, Elasthane™,Texin®, Tecothane®), polyamide polyether block copolymer (e.g. Pebax®,nylon 12), polyethylene, or other materials suitable for the purposes ofthe present disclosure. The material for jacket 400 may also includematerials to add radiopacity so that capsule 108 can be radio detectable(radiopaque). Wire structure 200 may be formed, for example, and not byway of limitation, of nickel titanium, Nitinol,nickel-cobalt-chromium-molybdenum (MP35N), stainless steel, high springtemper steel, or any other metal or elastomer or composite havingelastic properties to permit extension and recoil suitable for purposesof the present disclosure. Wire structure 200 is of a shape memorymaterial with a pre-set shape. In an embodiment, wire structure 200 hasa pre-set shape in the collapsed configuration with outer diameterOD_(e), as shown in FIG. 8A. Wire structure 200 allows capsule 108 toexpand to outer diameter OD_(e) when in the expanded configuration, asshown in FIG. 8B, with the stented prosthetic heart valve (not shown) inthe radially compressed delivery configuration within capsule 108. Dueto the shape memory material and pre-set shape thereof, wire structure200 causes capsule 108 to actively recoil to the reduced outer diameterOD_(c) after release of the stented prosthetic heart valve from capsule108. As previously stated, outer diameter OD_(e) is greater than outerdiameter OD_(c) and outer diameter OD_(c) is smaller than the innerdiameter ID_(a) of outer stability shaft 110.

While wire structure 200 has been previously described with a pre-setshape in the collapsed configuration with outer diameter OD_(c), this isnot meant to limit the design, and wire structure 200 can alternativelyhave a pre-set shape in the expanded configuration with outer diameterOD_(e), or any other configuration between the collapsed and expandedconfiguration based upon the application.

Liner 300 is circumferentially continuous and forms a lumen 224, asshown in FIG. 5. Wire structure 200 and jacket 400 arenon-circumferentially continuous and includes a jacket gap 440 visiblein the expanded configuration, as shown in FIG. 8B. In the collapsedconfiguration, as shown in FIGS. 5, capsule 108 includes a liner overlapregion 310 and a jacket overlap region 410. Liner overlap region 310includes a liner gap portion 340 defined by an inner fold 320 and anouter fold 330 of liner 300. Liner gap portion 340 can be at leastpartially covered by jacket 400. Liner 300 extends around an inner edge420 to form inner fold 320. Jacket overlap region 410 is defined byinner edge 420 and an outer edge 430 of jacket 400. In the expandedconfiguration, inner edge 420 and outer edge 430 are separatedcircumferentially to form jacket gap 440, as shown in FIG. 8B. In such aconfiguration, inner fold 320 and outer fold 330 are flattened orstretched apart to allow liner gap portion 340 to extend across jacketgap 440.

As previously stated, wire structure 200 has a pre-set shape that allowscapsule 108 to collapse to reduced outer diameter OD_(c) after releaseof the stented prosthetic heart valve from capsule 108. Moreparticularly, as shown in FIGS. 6-7, wire structure 200 includes arepeating longitudinal pattern and is shown in a flat, or uncurved,state. For example, and not by way of limitation, wire structure 200 mayinclude a sinusoid pattern 250 (FIG. 6A), a square pattern 260 (FIG.6B), a modified square pattern 270 including a spine 276 (FIG. 6C), amodified square pattern 280 including a preferential bend portion (FIG.6D), and a modified square pattern 290 including a stepped portion (FIG.6E). Sinusoid pattern 250, as shown in FIG. 6A, includes a series ofalternating adjacent straight portions 202 a and 202 b. Each straightportion 202 a is joined to a first adjacent straight portion 202 b by afirst bent end portion 204 a, and to a second adjacent straight portion202 b by a second bent end portion 204 b. Conversely, each straightportion 202 b is joined to two straight portions 202 a by first bent endportion 204 a and second bent end portion 204 b.

Square pattern 260, as shown in FIG. 6B, includes a series ofalternating adjacent straight portions 262 a and 262 b. Each straightportion 262 a is joined to a first adjacent straight portion 262 b by afirst end portion 264 a, and to a second adjacent straight portion 262 bby a second end portion 264 b. Conversely, each straight portion 262 bis joined to two straight portions 262 a by first end portion 264 a andsecond end portion 264 b.

Modified square pattern 270, as shown in FIG. 6C, includes a series ofalternating adjacent straight portions 272 a and 272 b. Each straightportion 272 a is joined to a first adjacent straight portion 272 b by afirst end portion 274 a, and to a second adjacent straight portion 272 bby a second end portion 274 b. Conversely, each straight portion 272 bis joined to two straight portions 272 a by first end portion 274 a andsecond end portion 274 b. A spine 276 extends along end portions 274 b.Spine 276 adds additional tensile rigidity to wire structure 200. Endportions 274 b adjacent spine 276 may be coupled to spine 276, forexample, and not by way of limitation, by welding, adhesives, or othermaterials suitable for the purposes described herein.

Modified square pattern 280, as shown in FIG. 6D, includes a series ofalternating adjacent straight portions 282 a and 282 b. Each straightportion 282 a is joined to a first adjacent straight portion 282 b by afirst end portion 284 a, and to a second adjacent straight portion 282 bby either a second end portion 284 b or a preferential bending portion284 c. Conversely, each straight portion 282 b is joined to two straightportions 282 a by first end portion 284 a and either second end portion284 b or preferential bending portion 284 c. A spine 286 extends alongend portions 284 b and preferential bending portion(s) 284 c.Preferential bending portion(s) 284 c provides increased flexibility towire structure 200 in the area of preferential bending portion(s) 284 cby forming a disjointed or segmented portion of modified square pattern280 which has no straight portions 282 a and 282 b. More particularly,in an embodiment, preferential bending portion(s) 284 c provides thecapsule with flexibility to bend during tracking and delivery. Statedanother way, the capsule is permitted to bend at preferential bendingportion(s) 284 c due to the absence of straight portions 282 a and 282 balong the length of preferential bending portion(s) 284 c. In anotherembodiment, preferential bending portion(s) 284 c provides the capsulewith two different expansions zones (i.e., an expansion zone on bothsides of the preferential bending portion). Although illustrated at anintermediate portion of wire structure 200, the position of preferentialbending portion(s) 284 c may vary. In addition, although shown with onlyone preferential bending portion 284 c, wire structure 200 may include aplurality of preferential bending portions 284 c spaced apart along thelength of spine 286. Spine 286 adds additional tensile rigidity to wirestructure 200. End portion 284 b and preferential bending portion(s) 284c adjacent spine 286 may be coupled to spine 286, for example, and notby way of limitation, by welding, adhesives, or other materials suitablefor the purposes described herein.

Modified square pattern 290, as shown in FIG. 6E, includes a series ofalternating adjacent straight portions 292 a and 292 b having a firstlength L1 along a distal portion 297 of wire structure 200. Modifiedsquare pattern 290 further includes a series of alternating adjacentstraight portions 292 c and 292 d having a second length L2 along aproximal portion 298 of wire structure 200. In the embodiment of FIG.6E, the first length L1 of each straight portion 292 a and 292 b isgreater than the second length L2 of each straight portion 292 c and 292d. For distal portion 297 of wire structure 200, each straight portion292 a is joined to a first adjacent straight portion 292 b by a firstend portion 294 a, and to either a second adjacent straight portion 292b, or for the straight portion 292 a at a proximal end of distal portion297 to a second adjacent straight portion 292 c, by a second end portion294 b. Conversely, each straight portion 292 b is joined to two straightportions 292 a by first end portion 294 a and second end portion 294 b.For the proximal portion 298 of wire structure 200, each straightportion 292 c is joined to a first adjacent straight portion 292 d by afirst end portion 294 a, and to either a second adjacent straightportion 282 d, or for the straight portion 292 c at a distal end ofproximal portion 298 to a second adjacent straight portion 292 b, by asecond end portion 294 b. Conversely, each straight portion 292 d isjoined to two straight portions 292 c by first end portion 294 a andsecond end portion 294 b. As shown in FIG. 6F, the first length L1 andthe second length L2 of straight portions 292 a/ 292 b and 292 c/ 292 d,respectively, form a stepped profile with a first diameter D1 over thedistal portion 297 and a second diameter D2 over the proximal portion298. First diameter D1 is greater than second diameter D2. The steppedprofile of modified square pattern 290 in turn provides the capsule witha stepped profile (not shown), the stepped profile capsule beingconfigured to receive a stented prosthetic heart valve therein asdescribed previously. More specifically, the stepped profile capsuleaccommodates a stented prosthetic heart valve with larger diameter at adistal portion thereof. For example, a stented prosthetic heart valvemay have an additional component at the distal portion thereof thatcauses the distal portion of the stented prosthetic heart valve to havea larger diameter such as, but not limited to a sealing componentconfigured to prevent paravalvular leakage (PVL) such as a skirt, acuff, or a sleeve. A sealing component increases the collapsed diameterof the stented prosthetic heart valve over the area of the stentedprosthetic heart valve to which it is coupled. Therefore, in the exampleof FIGS. 6E-6F, the wire structure 200 with an increased first diameterD1 over distal portion 297 accommodates a stented prosthetic heart valvewith larger diameter at a distal portion thereof. While the steppedconfiguration is described herein with a greater diameter over thedistal portion 297, this is not meant to be limiting and the greaterdiameter portion may be disposed over proximal portion 298, or overother portions there between based upon the application. In addition,although shown with a single stepped portion, wire structure 200 mayinclude a plurality of stepped portions spaced apart along the length ofa spine 296 to provide a plurality of outer diameters. Further, ratherthan a single abrupt stepped portion as shown, wire structure 200 mayinclude a plurality of small, adjacent stepped portions thatcollectively form a single tapered stepped portion. Spine 296 extendsalong end portions 294 b. Spine 296 adds additional tensile rigidity towire structure 200. End portions 294 b adjacent spine 296 may be coupledto spine 296, for example, and not by way of limitation, by welding,adhesives, or other materials suitable for the purposes describedherein.

The below discussion refers to sinusoidal portion 250 of wire structure200, however, square pattern 260 or modified square patterns 270, 280,290 could also be used for wire structure 200. As shown in FIGS. 6A, 7A,and 7B, along the length of capsule 108, the straight portions of wirestructure 200 are curved about a longitudinal axis LA2 into a C- shapedwire structure 200 forming a series of non-continuous circumferentialloops. To form the non-continuous circumferential loops, a first loopportion 212 of straight portions 202 a and 202 b joined by first bentend portion 204 a is curved in a first radial direction 210. A secondloop portion 222 of straight portions 202 a and 202 b joined by secondbent end portion 204 b is curved in a second radial direction 220. Firstloop portions 212 and second loop portions 222 form a series ofalternating non-continuous circumferential loops extending alonglongitudinal axis LA2. In the collapsed configuration of capsule 108,first loop portions 212 and second loop portions 222 overlapcircumferentially as demonstrated by a wire region 214, as shown in FIG.7B. When capsule 108 is in the collapsed configuration, first loopportions 212 are positioned within second loop portions 222 in wireregion such that the second loop portions 222 cover the first loopportions 212. When capsule 108 is in the expanded configuration, firstloop portions 212 and second loop portions 222 do not overlap and do notinclude wire region 214. Stated another way, as capsule 108 transitionsbetween the collapsed configuration and the expanded configuration,circumferential portions 212 and 222 of wire structure 200 expand andcollapse, thereby expanding and collapsing wire region 214.

Capsule 108, as shown in FIGS. 8A and 8B, is designed to allow for localexpansion and subsequent recoil to retain and release the stentedprosthetic heart valve as previously described. While introducing thestented prosthetic heart valve to capsule 108 for delivery to thetreatment site within the patient, capsule 108 can transition from thecollapsed configuration having outer diameter OD_(c) (FIG. 8A) to theexpanded configuration having outer diameter OD_(e) (FIG. 8B) toaccommodate the stented prosthetic heart valve (not shown). Thisincrease in diameter is accomplished by first loop portions 212 andsecond loop portions 222 of wire structure 200, as shown in FIGS. 7A and7B, and inner edge 420 and outer edge 430 of jacket 400, as shown inFIGS. 8A and 8B diverging circumferentially to increase the effectivediameter of capsule 108. As capsule 108 increases in diameter, innerfold 320 and outer fold 330 are flattened or stretched apart to allowliner gap portion 340 to span across jacket gap 440. Thus, liner gapportion 340 extends across jacket gap 440 and maintains acircumferentially continuous structure. Upon release of the stentedprosthetic heart valve (not shown) at the treatment site within thepatient, capsule 108 transitions from the expanded configuration, havingouter diameter OD_(e), to the collapsed configuration, having outerdiameter OD_(c). As previously described, the collapsed configuration,with outer diameter OD_(c), of capsule 108 is smaller than the innerdiameter ID_(a) of outer stability shaft 110.

FIGS. 9A-9C and FIGS. 10A-10B illustrate another embodiment of a capsule508 that is configured to be collapsible upon retraction thereof into anouter stability shaft 510 (not shown in FIGS. 9A-10A) according to anembodiment hereof. Capsule 508 may be utilized in delivery device 500 asdescribed above with respect to delivery device 100. As described abovewith respect to capsule 108 and proximal shaft 118, capsule 508 iscoupled to a proximal shaft 518, shown in FIG. 10A. Capsule 508 includesa generally tubular polymeric structure 570 and a plurality ofreinforcing members 574. As best shown in FIGS. 10A and 10B, reinforcingmembers 574 are axially spaced longitudinal metallic or polymeric wiresor rods disposed within and providing compressive strength to capsule508. Reinforcing members 574 are arranged parallel to longitudinal axisLA_(d) and coupled to an inner surface of polymeric structure 570.Reinforcing members 574 may be, for example, and not by way oflimitation, stainless steel, Nitinol, nylon, polybutylester, or othermaterials suitable for the purposes described herein. Reinforcingmembers 574 are coupled to polymeric structure 570, for example, and notby way of limitation, by fusing, welding, adhesive, sutures, or othermeans suitable for the purposed described herein. While FIGS. 9A-10Bshow four (4) reinforcing members 574 within polymeric structure 570,this is not meant to limit the design and more or fewer reinforcingmembers may be employed. Further, reinforcing members 574 may be coupledto an outer surface of polymeric structure 570.

In an embodiment, polymeric structure 570 of capsule 508 is of a shapememory material with a pre-set shape in a relaxed or intermediateconfiguration of FIG. 9B in which no forces are applied thereto. In therelaxed configuration, capsule 508 has a third outer diameter OD_(r).Polymeric structure 570 is an elastic structure that allows capsule 508to stretch or expand to an expanded configuration in which capsule 508has a first outer diameter OD_(e) as shown in FIG. 9A, when a stentedprosthetic heart valve (not shown) in a radially compressed deliveryconfiguration is disposed therein. Stated another way, when a stentedprosthetic heart valve is positioned therein, polymeric structure 570and reinforcing members 574 attached thereto radially expand toaccommodate the stented prosthetic heart valve. The elastic propertiesof polymeric structure 570 also allow capsule 508 to actively recoilback to third outer diameter OD_(r) of the relaxed configuration afterrelease of the stented prosthetic heart valve (not shown). First outerdiameter OD_(e) of capsule 508 is greater than third outer diameterOD_(r) of capsule 508. Further, the elastic properties of polymericstructure 570 also allow capsule 508 to fold to a collapsed or foldedconfiguration in which capsule 508 has a second outer diameter OD_(c) asshown in FIG. 9C, when capsule 508 is retracted into outer stabilityshaft 510. Outer stability shaft 510 has an inner diameter ID_(a). Ascapsule 508 is retracted into outer stability shaft 510, outer stabilityshaft 510 imparts compressive radial force on capsule 508, resulting inportions of polymeric structure 570 disposed between adjacentreinforcing members 574 folding inward, towards longitudinal axis LA_(d)of capsule 508, and reducing capsule 508 to second outer diameterOD_(c). Polymeric structure 570 may be of a thin-walled polymericmaterial, for example, and not by way of limitation, polyester,elasthane or any other material suitable for the purpose describedherein.

While polymeric structure 570 has been described herein as having apre-set shape in the relaxed configuration of FIG. 9B with third outerdiameter OD_(r), polymeric structure 570 can alternatively have thepre-set shape in the expanded configuration of FIG. 9A with first outerdiameter OD_(e), the pre-set shape in the collapsed configuration ofFIG. 9C with second outer diameter OD_(c), or any other configurationbetween the collapsed and expanded configuration based upon theapplication. When the polymeric structure has a pre-set shape in theexpanded configuration, loading forces on the stented prosthetic heartvalve are minimized and when the polymeric structure has a pre-set shapein the collapsed configuration, deployment forces on the stentedprosthetic heart valve are minimized by reducing the force required topull the polymeric structure into the outer stability shaft.

In another embodiment, as described above with respect to deliverydevice 500, capsule 508, and polymeric structure 570, polymericstructure 970 of capsule 908 of delivery device 900 is of a shape memorymaterial with a pre-set shape in an expanded configuration of FIG. 10Cin which no forces are applied thereto. In the expanded configuration,capsule 908 has a first outer diameter OD_(e). Polymeric structure 970is a non-elastic structure that allows capsule 908 to impart compressiveradial forces on a stented prosthetic heart valve (not shown) in aradially compressed delivery configuration disposed therein. Polymericstructure 970 allows capsule 908 to fold to a collapsed or foldedconfiguration in which capsule 908 has a second outer diameter OD_(c) asshown in FIG. 10D, when capsule 908 is retracted into outer stabilityshaft 910. Outer stability shaft 910 has an inner diameter ID_(a). Ascapsule 908 is retracted into outer stability shaft 910, outer stabilityshaft 910 imparts compressive radial force on capsule 908, resulting inportions of polymeric structure 970 disposed between adjacentreinforcing members 974 folding inward, towards longitudinal axis LA_(d)of capsule 908, and reducing capsule 908 to second outer diameterOD_(D). Polymeric structure 970 may be of a thin-walled polymericmaterial, for example, and not by way of limitation, polypropylene orany other materials suitable for the purpose described herein.

In any embodiment hereof, an outer stability shaft of a delivery devicemay be modified to include a steering mechanism to enable the centeringof a delivery device within a valve annulus. For example, FIGS. 11-12illustrate a steering mechanism 652 coupled to an outer stability shaft610 of delivery device 600. Delivery device 600 is similar to deliverydevice 100 as previously described herein. Delivery device 600 includesa capsule assembly 607, outer stability assembly 610, and inner shaftassembly 614, as shown in FIG. 11A. Similar to capsule assembly 107,capsule assembly 607 includes a capsule 608 and a proximal shaft 618 aspreviously described. Steering mechanism 652 of delivery device 600includes a steering actuator 648 at a handle 640, as shown in FIG. 11A,and a plurality of pull cable shafts 660 defining a plurality of lumen661 with a plurality of pull cables 662 disposed therein, as shown inFIG. 12. Pull cables 662 include a proximal end (not shown) coupled tosteering actuator 648 of handle 640 and a distal end (not shown) coupledto a distal end 626 of outer stability shaft 610, and disposed withinrespective lumens 661, therein. Cable shafts 660 may be connected to aninner surface of outer stability shaft 610 for example, and not by wayof limitation, by fusing, welding, adhesive, sutures, or other meanssuitable for the purposed described herein. Proximal ends (not shown) ofpull cables 662 may be connected to steering actuator 648 of handle 640for example, and not by way of limitation, by fusing, welding, adhesive,sutures, or other means suitable for the purposed described herein.Distal ends (not shown) of pull cables 662 may be connected to distalend 626 of outer stability shaft 610 for example, and not by way oflimitation, by welding, adhesive, sutures, or other means suitable forthe purposed described herein. While the steering embodiment of FIGS.11-12 show pull cable shafts 660 and respective pull cables 662 disposeddirectly across from each other, or at 180 degrees from each other on aninterior surface of outer shaft 610, this is not meant to be limitingand other configurations of pull shafts 660 and respective pull cables662 are envisioned. For example, and not by way of limitation, pullshafts 660 and their respective pull cables 662 may be disposed at 90degrees from each other such that outer shaft 610 may be steered in two(2) planes.

Delivery device 600 includes a capsule 608 configured to be collapsed onretraction thereof into outer stability shaft 610. As capsule 608 isconfigured to be collapsed on retraction thereof into outer stabilityshaft 610, capsule 608 is disposed directly adjacent to distal end 626of outer stability shaft 610, as shown in FIG. 11A, with the capsule inan expanded configuration and FIG. 11B, with capsule 608 in a collapsedconfiguration. Capsule 608 being disposed directly adjacent to distalend 626 of outer stability shaft 610 minimizes a gap distance G2, thusminimizing a lever arm L2. Steering actuator 648 of delivery device 600may be user manipulated left or right relative to a longitudinal axisLA_(d) of handle 640. Steering mechanism 652 is configured such thatuser manipulation left or right of steering actuator 648 is translatedthough pull cables 662, as shown in FIG. 12, to a user definable singleplanar movement PM_(I2), or PM_(r2) relative to longitudinal axisLA_(d), and a deflection distance D_(d2) of distal end 626 of outershaft 610, as shown in FIG. 11C. Since capsule 608 is disposed directlyadjacent to distal end 626 of outer stability shaft 610, a minimizedlever arm L2 is reduced or shortened relative to lever arm L1 discussedwith respect to FIG. 1A. The minimized lever arm L2 results in improvedsteering accuracy and smaller planer movement PM_(I2) and PM_(r2) andsmaller deflection distance D_(d2) of capsule 608 and a stentedprosthetic heart valve therein, relative to the planer movements anddeflection distance discussed with respect to FIG. 1A. Stated anotherway, with collapsible capsule 608 disposed directly adjacent to distalend 626 of outer stability shaft 610, small movements of steeringactuator 648, combined with the minimized length of lever arm L2resulting thereof, translate to relatively small planar movement PM_(I2)or PM_(r2) and small, precise deflection distance D_(d2) of capsule 608and the stented prosthetic heart valve retained therein.

A method of manipulating a delivery device with a stented prostheticheart valve loaded therein, in accordance with an embodiment hereof, isschematically represented in FIGS. 13A-13C. Using establishedpercutaneous transcatheter delivery procedures, delivery device 100 isintroduced into a patient's vasculature and positioned at a treatmentsite of a damaged or diseased native valve, which in this embodiment isa native aortic valve 714. Delivery device 100 includes a handle (notshown), outer stability shaft 110, proximal shaft 118, inner shaft 114,and capsule assembly 107 as previously described. Delivery device 100 isadvanced through the aorta 700 (including the aortic arch 704 (passingthe innominate or brachiocephalic artery 716, the left common carotidartery 718, and the left subclavian artery 720, ascending aorta 702,sinotubular junction 710, aortic sinuses 712) to a valve annulus 708 andbetween native valve leaflets 715 of the damaged or disease nativeaortic valve 714, as shown in FIG. 13A. Although described herein withdelivery device 100, it will be apparent to one of ordinary skill thatmethods described herein may utilize a delivery device according to anyembodiment described herein. In FIG. 13A, capsule 108 of capsuleassembly 107 is in the expanded configuration and is positioned over astented prosthetic heart valve 800 (obscured from view in FIG. 13A).

Next, actuator mechanism 144 of handle 140 (not shown on FIGS. 13A-13C)is operated proximally to retract capsule assembly 107. In particular,proximal shaft 118 and capsule 108 are moved proximally to withdrawcapsule 108 from its position surrounding stented prosthetic heart valve800, and retract capsule 108 into lumen 128 (not shown on FIGS. 13A-13C)of outer stability shaft 110, as shown in FIG. 13B. As capsule 108 isretracted proximally, capsule 108 transitions from the expandedconfiguration with outer diameter OD_(e) to the collapsed configurationwith outer diameter OD_(c). As previously described herein, outerdiameter OD_(c) of capsule 108 is smaller than outer diameter OD_(e) ofcapsule 108 and is also smaller than inner diameter ID_(a) of outerstability shaft 110. Of note, as stented prosthetic heart valve 800expands, it traps native leaflets 715 against the wall of valve annulus708.

Once stented prosthetic heart valve 800 is fully deployed and in theradially expanded deployed configuration (with native valve leaflets 715disposed between the wall of valve annulus 708 and an outer surface ofstented prosthetic heart valve 800), as shown in FIG. 13C, deliverydevice 100 may be retracted and removed from the patient's vasculatureusing established procedures.

Another method of manipulating a delivery device with a stentedprosthetic heart valve loaded therein, in accordance with an embodimenthereof, is schematically represented in FIGS. 14A-14E. The method stepsof FIGS. 14A-14E are described with respect to delivery device 600 thatincludes steering mechanism 652 as described above. Using establishedpercutaneous transcatheter delivery procedures, delivery device 600 isintroduced into a patient's vasculature and positioned longitudinally atthe site of a damaged or diseased native valve, which in this embodimentis the native aortic valve 714. Delivery device 600 includes a handle(not shown), outer stability shaft 610, proximal shaft 618, inner shaft614, steering mechanism 652 (not shown in FIGS. 14A-14E), and capsuleassembly 607 as previously described. Delivery device 600 is advancedthrough the aorta 700 (including the aortic arch 704 (passing theinnominate or brachiocephalic artery 716, the left common carotid artery718, and the left subclavian artery 720, ascending aorta 702,sinotubular junction 710, aortic sinuses 712) to valve annulus 708 andbetween native valve leaflets 715 of the damaged or disease nativeaortic valve 714, as shown in FIG. 14A. In FIG. 14A, capsule 608 ofcapsule assembly 607 is in the expanded configuration and is positionedover stented prosthetic heart valve 800 (obscured from view in FIG.14A). Capsule 608 is not centered on longitudinal axis LA_(v) of valveannulus 708.

Next the centered position of capsule 608 relative to longitudinal axisLA_(v) of valve annulus 708 may be adjusted using steering mechanism 652(not shown in FIGS. 14A-14E) coupled to outer stability shaft 610.Steering actuator 648 (not shown) of steering mechanism 652 (not shown)of delivery device 600 is manipulated by the user to move capsule 608 indirection PM_(I2) the deflection distance D_(d2) to center capsule 608on longitudinal axis LA_(v) at the desired deployment location, as shownin FIG. 14B. With capsule 608 being collapsible and disposed directlyadjacent to distal end 626 (not shown) of outer stability shaft 610 aspreviously described rather than spaced apart therefrom, small movementsof steering actuator (not shown), translate to relatively small planarmovement PM_(I2) and relatively small, precise deflection distanceD_(d2) of capsule 608 and stented prosthetic heart valve 800 (obscuredin FIG. 14B) retained therein. Determination of desired deploymentlocation and centering may be based upon known methods, for example, andnot by way of limitation, such as sonography and radiopaque markers.

With capsule 608 in the desired delivery location and centered on valveannulus 708, as shown in FIG. 14C, stented prosthetic heart valve 800 isnow deployed. Actuator mechanism 644 of handle 640 (not shown in FIGS.14A-14E) is operated proximally to retract capsule assembly 607. Inparticular, proximal shaft 618 and capsule 608 are moved proximally towithdraw capsule 608 from its position surrounding stented prostheticheart valve 800, and retract capsule 608 into lumen 628 (not shown onFIGS. 14A-14E) of outer stability shaft 610, as shown in FIG. 14D. Ascapsule 608 is retracted proximally, capsule 608 transitions from theexpanded configuration with outer diameter OD_(e) to the collapsedconfiguration with outer diameter OD_(c). As described previously, outerdiameter OD_(c) of capsule 608 is smaller than outer diameter OD_(e) ofcapsule 608 and is also smaller than inner diameter ID_(a) of outerstability shaft 610. As stented prosthetic heart valve 800 expands, ittraps native leaflets 715 against the wall of valve annulus 708.

Once stented prosthetic heart valve 800 is fully deployed and in theradially expanded deployed configuration, (with native valve leaflets715 disposed between the wall of valve annulus 708 and an outer surfaceof stented prosthetic heart valve 800), as shown in FIG. 14E, deliverydevice 600 may be retracted and removed from the patient's vasculatureusing established procedures.

FIGS. 15-16 show a delivery device 1500 according to another embodimenthereof. Similar to delivery device 100, delivery device 1500 includesouter stability shaft 110, capsule assembly 107, and inner shaftassembly 104. Outer stability shaft 110, capsule assembly 107, and innershaft assembly 104 of delivery device 1500 are described above withrespect to delivery device 100, and therefore construction anddescription of these components will not be repeated in detail. However,unlike delivery device 100, delivery device 1500 further includes adelivery capsule assembly 150.

Delivery capsule assembly 150 is coaxially and slidably disposed betweeninner shaft assembly 104 and capsule assembly 107. Stated another way,delivery capsule assembly 150 may be longitudinally moved relative toinner shaft assembly 104, capsule assembly 107, and outer stabilityshaft 110. With reference to FIGS. 15-16, delivery capsule assembly 150includes a delivery capsule 152 and a delivery shaft 154, and defines alumen 156 extending from a proximal end 158 of delivery shaft 154 to adistal end 160 of delivery capsule 152. Although delivery capsuleassembly 150 is described herein as including delivery capsule 152 anddelivery shaft 154, delivery capsule 152 may simply be an extension ofdelivery shaft 154. The length and thickness of delivery capsule 152 aredetermined by the requirements of the specific application. Deliveryshaft 154 is configured for fixed connection to delivery capsule 152 ata connection point 162 at a proximal end 164 of delivery capsule 152 forexample, and not by way of limitation, by fusing, welding, adhesive,sutures, or other means suitable for the purposes described herein, andextends proximally from delivery capsule 152, with delivery shaft 154configured for fixed connection to a handle 1540. Handle 1540 is similarto handle 140 described previously, except that handle 1540 includes asecond actuator mechanism 1544 for actuating delivery capsule assembly150. In an embodiment, second actuator mechanism 1544 extends throughlongitudinal slot 146 for interfacing by a user. Second actuatormechanism 1544 is generally constructed to provide selectiveretraction/advancement of delivery capsule assembly 150 and can have avariety of constructions and/or devices capable of providing the desireduser interface. Second actuator mechanism 1544 is further described inU.S. Pat. No. 8,579,963 to Tabor, previously incorporated by reference.

More particularly, delivery shaft 154 of delivery capsule assembly 150extends proximally into housing 142 of handle 1540 and a proximalportion 166 of delivery shaft 154 is rigidly connected to deliveryactuator mechanism 1544 of handle 1540. Proximal portion 166 is coupledto delivery actuator mechanism 1544 such that movement of deliveryactuator mechanism 1544 causes delivery capsule assembly 150 to moverelative to outer stability shaft 110 capsule assembly 107, and innershaft assembly 104. Delivery shaft 154 may be coupled to deliveryactuator mechanism 1544, for example, and not by way of limitation byadhesives, welding, clamping, and other coupling devices as appropriate.Delivery capsule assembly 150 is thus movable relative to handle 1540,outer stability shaft 110, capsule assembly 107, and inner shaftassembly 104 by delivery actuator mechanism 1544. However, if deliveryactuator mechanism 1544 is not moved and handle 1540 is moved, deliverycapsule assembly 150 moves with handle 1540, not relative to handle1540.

According to embodiments hereof, delivery capsule 152 is configured tobe collapsible upon retraction thereof into capsule assembly 107.Delivery capsule 152 is a thin-walled capsule designed to minimizecrossing profile of the stented prosthetic heart valve loaded thereinfor introduction into a body. Delivery capsule 152 may be formed ofmaterials such as, but no limited to materials similar to those used inthe construction of angioplasty balloons, such as polyethyleneterephthalate (PET), nylon, or other materials suitable for the purposesdescribed herein. FIG. 16 shows delivery device 1500 with deliverycapsule 152 in the expanded configuration, in which a stented prostheticheart valve (not shown) is held in a radially compressed deliveryconfiguration therein. Stated another way, delivery capsule 152 in theexpanded configuration functions to retain or hold the stentedprosthetic heart valve in the radially compressed configuration fordelivery thereof. When retracted, delivery capsule 152 collapses intocapsule assembly 107 due to the thin-walled material of delivery capsule152. Thus, delivery capsule 152 transitions from the expandedconfiguration to the collapsed configuration when retracted into capsuleassembly 107. Delivery capsule 152 retracts into lumen 112 of capsuleassembly 107 such that delivery capsule 152 does not surround thestented prosthetic heart valve, and the stented prosthetic heart valveradially expands to its radially expanded deployed configuration.

Capsule assembly 107 is coaxially and slidably disposed between deliverycapsule assembly 150 and outer stability shaft 110. In an embodiment,capsule assembly 107 and more specifically capsule 108 may be utilizedto provide additional support to delivery capsule 152 during trackingthrough a vasculature to a treatment site. For example, delivery capsule152 having a minimized crossing profile may be disposed over a stentedprosthetic heart valve during introduction into the body and capsule 108may be in its collapsed configuration within outer stability shaft 110during introduction into the body. After introduction into the body,capsule 108 may be advanced from the collapsed configuration withinouter stability shaft 110 until capsule 108 is in its expandedconfiguration and disposed over delivery capsule 152 to provideadditional support during advancement to the treatment site. FIG. 16shows delivery device 1500 with delivery capsule 152 in the expandedconfiguration, in which a stented prosthetic heart valve (not shown) isheld in a radially compressed delivery configuration therein, andcapsule 108 is also in the expanded configuration and disposed overdelivery capsule 152.

In another embodiment, capsule assembly 107 and more specificallycapsule 108 is configured for recapture of a partially deployed stentedprosthetic heart valve. More particularly, in situations where thestented prosthetic heart valve is partially released from deliverycapsule 152 and recapture by the weaker (relative to capsule 108)delivery capsule 152 is not possible at body temperature, the stronger(relative to delivery capsule 152) capsule 108 may be advanced torecapture the partially deployed stented prosthetic heart valve. Thus,delivery capsule 152 having a minimized crossing profile is utilized forradially collapsing a stented prosthetic heart valve and tracking itthrough a vasculature, while capsule 108 is utilized on an as-neededbasis for recapture and repositioning of a partially deployed stentedprosthetic heart valve.

In embodiments described above, capsule 108 in the expandedconfiguration functions to retain or hold the stented prosthetic heartvalve in a radially compressed configuration for delivery thereof.However, in other embodiments, capsule 108 may utilized solely in aprotective manner for the stented prosthetic heart valve and other meansmay be utilized for expanding the stented prosthetic heart valve. Forexample, in another embodiment hereof, capsule 108 is configured toprotect a balloon expandable stented prosthetic heart valve and thesurrounding native anatomy as capsule 108 with the stented prostheticheart valve disposed therein is advanced to a treatment site. Thus,capsule 108 is for protection only, as the stented prosthetic heartvalve is not self-expanding and therefore does not require the capsule108 to radially collapse and restrain the stented prosthetic heart valvewhen disposed therein. Once the stented prosthetic heart valve is at thetreatment site, the capsule assembly 107 is retracted to expose thestented prosthetic heart valve. The stented prosthetic heart valve maythen be steered to the desired treatment position and expanded byballoon inflation, as will be understood by one skilled in the art. Inyet another embodiment, the stented prosthetic heart valve isself-expanding and restrained by a cinch mechanism or sutures fordelivery to a desired treatment site. Examples of suitable cinchmechanisms for retaining self-expanding valve prostheses are describedin U.S. Patent Publication No. 2014/0330368 to Gloss, which isincorporated herein by reference in its entirety. In such an embodiment,capsule 108 is configured only for protection of the stented prostheticheart valve and the native anatomy during introduction and advancementof the stented prosthetic heart valve to the treatment site. Once thestented prosthetic heart valve is at the treatment site, capsuleassembly 107 is retracted and collapsed in outer stability shaft 110 toexpose the stented prosthetic heart valve. The stented prosthetic heartvalve is then deployed at the treatment site by releasing the suturessuch that the stented prosthetic heart valve radially expands at thetreatment site.

While only some embodiments have been described herein, it should beunderstood that it has been presented by way of illustration and exampleonly, and not limitation. Various changes in form and detail can be madetherein without departing from the spirit and scope of the invention,and each feature of the embodiment discussed herein, and of eachreference cited herein, can be used in combination with the features ofany other embodiment. All patents and publications discussed herein areincorporated by reference herein in their entirety.

1-9. (canceled)
 10. A delivery device for percutaneously delivering astented prosthetic heart valve, the stented prosthetic heart valve beingradially expandable from a radially compressed delivery configuration toa radially expanded deployed configuration, the delivery devicecomprising: a capsule assembly, wherein the capsule assembly includes acapsule and a proximal shaft coupled to a proximal end of the capsule,the capsule including an expanded configuration wherein the capsule isconfigured to compressively constrain the stented prosthetic heart valvein the radially compressed delivery configuration during deliverythereof through a vasculature, and a collapsed configuration wherein thecapsule is configured to not surround the stented prosthetic heartvalve; a handle including a housing and an actuator mechanism, whereinthe actuator mechanism is coupled to a proximal portion of the proximalshaft and is configured to selectively move the proximal shaft and thecapsule relative to the housing to release the stented prosthetic heartvalve; and an outer stability shaft defining a lumen, the outerstability shaft coupled to the handle and configured to receive theproximal shaft within the lumen of the outer stability shaft, whereinthe proximal end of the capsule is disposed distal to a distal end ofthe outer stability shaft when the capsule is in the expandedconfiguration and the capsule is disposed within the lumen of the outerstability shaft when the capsule is in the collapsed configuration. 11.The delivery device of claim 10, wherein the capsule includes a firstouter diameter when in the expanded configuration and a second outerdiameter when in the collapsed configuration, wherein the second outerdiameter is smaller than the first outer diameter and the second outerdiameter is smaller than an inner diameter of the outer stability shaft.12. The delivery device of claim 11, wherein the capsule is formed froma shape memory material including a pre-set shape.
 13. The deliverydevice of claim 12, wherein the pre-set shape includes the capsule inthe collapsed configuration and the capsule is configured to be expandedto the expanded configuration to receive the stented prosthetic heartvalve.
 14. The delivery device of claim 12, wherein the pre-set shapeincludes the capsule in the expanded configuration and the capsule isconfigured to be compressed to the collapsed configuration as thecapsule is retracted into the lumen of the outer stability shaft. 15.The delivery device of claim 12, wherein the capsule comprises acircumferentially continuous layer, an elastic frame, and anon-circumferentially continuous layer connected to the elastic frameand to the circumferentially continuous layer, the non-circumferentiallycontinuous layer having a longitudinal gap in the expandedconfiguration.
 16. The delivery device of claim 11, wherein the capsulecomprises a polymeric material and a plurality of longitudinalreinforcing members coupled to the polymeric material.
 17. The deliverydevice of claim 16, wherein when the capsule is in the collapsedconfiguration, the polymeric material folds between the longitudinalreinforcing members and when the capsule is in the expandedconfiguration, the polymeric material forms a cylinder.
 18. The deliverydevice of claim 10, further comprising a steering mechanism coupled tothe outer stability shaft such that the outer stability shaft issteerable. 19-20. (canceled)
 21. The delivery device of claim 10,wherein the proximal end of the capsule is disposed directly adjacent tothe distal end of the stability shaft when the capsule is in theexpanded configuration.
 22. A system comprising: a stented prostheticheart valve radially expandable from a radially compressed deliveryconfiguration configured for delivery through a vasculature to aradially expanded deployed configuration; and a delivery device forpercutaneously delivering the stented prosthetic heart valve, thedelivery device including a capsule assembly, wherein the capsuleassembly includes a capsule and a proximal shaft coupled to a proximalend of the capsule, the capsule including an expanded configurationwherein the capsule has a first outer diameter and a collapsedconfiguration wherein the capsule has a second outer diameter smallerthan the first outer diameter; a handle including a housing and anactuator mechanism, wherein the actuator mechanism is coupled to aproximal portion of the proximal shaft and is configured to selectivelymove the proximal shaft and the capsule relative to the housing torelease the stented prosthetic heart valve; and an outer stability shaftdefining a lumen, the outer stability shaft coupled to the handle andconfigured to receive the proximal shaft within the lumen of the outerstability shaft, wherein when the capsule is in the expandedconfiguration, the proximal end of the capsule is disposed distal to adistal end of the outer stability shaft and the capsule compressivelyconstrains the stented prosthetic heart valve in the radially compresseddelivery configuration, and wherein when the capsule is in the collapsedconfiguration, the capsule does not surround the stented prostheticheart valve and is disposed within the lumen of the outer stabilityshaft.
 23. The delivery device of claim 22, wherein the capsule includesa first outer diameter when in the expanded configuration and a secondouter diameter when in the collapsed configuration, wherein the secondouter diameter is smaller than the first outer diameter and the secondouter diameter is smaller than an inner diameter of the outer stabilityshaft.
 24. The delivery device of claim 23, wherein the capsule isformed from a shape memory material including a pre-set shape.
 25. Thedelivery device of claim 24, wherein the pre-set shape includes thecapsule in the collapsed configuration with the second outer diameterand the capsule is configured to be expanded to the first outerdiameter.
 26. The delivery device of claim 24, wherein the pre-set shapeincludes the capsule in the expanded configuration with the first outerdiameter and the capsule is configured to be compressed to the secondouter diameter as the capsule is retracted into the lumen of the outerstability shaft.
 27. The delivery device of claim 24, wherein thecapsule comprises a circumferentially continuous layer, an elasticframe, and a non-circumferentially continuous layer connected to theelastic frame and to the circumferentially continuous layer, thenon-circumferentially continuous layer having a longitudinal gap when atthe first outer diameter.
 28. The delivery device of claim 23, whereinthe capsule comprises a polymeric material and a plurality oflongitudinal reinforcing members coupled to the polymeric material. 29.The delivery device of claim 28, wherein when the capsule is in thecollapsed configuration with the second outer diameter the polymericmaterial folds between the longitudinal reinforcing members, and whenthe capsule is in the expanded configuration with the first outerdiameter the polymeric material forms a cylinder.
 30. The deliverydevice of claim 22, wherein the delivery system further includes asteering mechanism coupled to the outer stability shaft such that theouter stability shaft is steerable.
 31. The delivery device of claim 22,wherein the proximal end of the capsule is disposed directly adjacent tothe distal end of the outer stability shaft when the capsule is in theexpanded configuration.